UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000007 |
|---|---|
| Receipt number | R000000010 |
| Scientific Title | A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone for steroid-resistant nephrotic syndrome in children: A randomized controlled study |
| Date of disclosure of the study information | 2005/08/01 |
| Last modified on | 2024/11/05 04:12:55 |
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Basic information
Public title
A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone for steroid-resistant nephrotic syndrome in children: A randomized controlled study
Acronym
A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone : A randomized controlled study(JSKDC02)
Scientific Title
A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone for steroid-resistant nephrotic syndrome in children: A randomized controlled study
Scientific Title:Acronym
A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone : A randomized controlled study(JSKDC02)
Region
| Japan |
Condition
Condition
Steroid-resistant nephrotic syndrome in children
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing a combination of cyclosporine and prednisolone and a combination methylprednisolone, cyclosporine and prednisolone,the better is selected as a standard treatment for steroid-resistant nephrotic syndrome in children in our group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete remission rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cyclosporine+prednisolone treatment for 2 years
Interventions/Control_2
Methylprednisolone+cyclosporine+prednisolone treatment for 2 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL).
2.Corticosteroid resistance after 4 weeks of daily prednisolone, or serum albumin level <2.5 g/dL after 4 subsequent weeks of alternate-day therapy, in cases of partial remission despite 4 weeks of daily prednisolone, based on the International study of kidney disease in children.
3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed within 8 weeks before eligibility.
4.Aged twelve months to 18 years.
5.Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria
1.Congenital nephrotic syndrome.
2.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus).
3.Medical history of allergy or hypersensitivity reactions to methylprednisolone and cyclosporine.
4.Poorly controlled hypertension.
5.Chronic renal dysfunction.
6.Active infectious disease.
7.Severe liver disfunction.
8.History of cyclosporine administration.
9.Pregnancy.
10.Judged inappropriate for this study by the physicians.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Ito |
Organization
National Center for Child Health and Development
Division name
Department of Pediatric Nephrology and Rheumatology
Zip code
157-8535
Address
2-10-1 Okura Setagaya-ku, Tokyo
TEL
03-3416-0181
info_jsrdc@jsrdc.org
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishikura |
Organization
Japanese Study Group of Kidney Disease in Children
Division name
Tokyo Metropolitan Children's Medical Center
Zip code
183-8561
Address
2-8-29 Musashidai Fuchu City, Tokyo
TEL
042-300-5111
Homepage URL
info_jsrdc@jsrdc.org
Sponsor or person
Institute
Japanese Study Group of Kidney Disease in Children
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Study Group of Renal Disease in Children
Address
1-15-1 Kitasato Minamiku Sagamihara City, Kanagawa
Tel
042-778-8111
info_jsrdc@jsrdc.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2005 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000010
